A Randomized Controlled Clinical Trial to evaluate the effect of Drakshadi leha in the management of Kaphaja Kasa in children

A RANDOMIZED CONTROLLED CLINICAL TRIAL TO EVALUATE THE EFFECT OF DRAKSHADI LEHA IN THE MANAGEMENT OF KAPHAJA KASA IN CHILDREN

NEED FOR THE STUDY:

Respiratory system is in continuous contact with the external environment since birth up till death. So respiratory tract infection account for more than 50% of the patients attending the paediatric OPD. Among the major causes of consultation at Primary Health Care Center the study has been carried by Pediatric Dept. among which 71.1% respiratory complaint [1]. Recurrent attack of cough shows a prevalence rate of 1.06%. Among them the maximum number of cases of the study were seen in the age of 5 to 10 years [2]. Some of the common side effects of practicing modern medicines in the management of cough are tremor, nervousness, headache, dizziness, hyperactivity, sleeplessness etc.

Kaphaja Kasa has been mentioned as one among five types of Kasa. It is the most commonest complaints in day to day practice and it is also a symptom of many diseases of respiratory system. [5]. Complaints of Kaphaja kasa are Aruchi , Chardi , Pinasa..etc[3]  To treat these complaints , Drakshadi yoga(leha) has been selected which contains drugs like Draksha[4], Pippali[4] and Shunthi[4]. They possess kaphahara, kasaahara and deepana properties.

As per our hypothesis this leha may help more in clearing up productive cough present in Kaphaja kasa and reduce the symptoms. This leha can be easily palatable and cost effective to be administered in children

REVIEW OF LITERATURE:

Ayurvedic classics have advised various formulations in the management of Kaphaja kasa. Kasa description regarding nidana, samprapti, poorvaroopa, bheda, lakshana, upashaya, anupashaya, upadrava and chikitsa from the Charaka Samhitha Chikitsasthana kasa chikitsa[3], sushrutha samhitha uttaratantra [5] and Kashyapa Samhitha in the context of Uroghata rog[6]

Cough is the protective reflex, its purpose being expulsion of respiratory secretions or foreign particles from air passages. Cough will also be reviewed from Modern Medical Texts.

The references of Drakhsadi yoga[7] and Talisadi churna[8][9] will be reviewed from Bhaishajya Ranatakar and Bhaishajya Ratnavali  and Sharangdhara  Samhita  Madhyama Khanda 6/132. The drugs present in the yoga and churna will be reviewed from different Nighantu and Samhitas

 PREVIOUS RESEARCH WORK

1. Dr.Praveen Mugabasav“Efficacy Of Duralabadi Leha V/S Talisadi Churna In The Treatment Of Kaphaja Kasa-A Randomized Comparative Clinical Study†Shri B.M.K Ayurveda Mahavidhyalaya Belgavi)
2. Dr.Anantamati N.Bammagol“Evaluation  Of The Efficacy Of  Ativishadi Yoga As An Antitussive Drug –A Randomised Control Clinical Trial† (Shri B.M.K Ayurveda Mahavidhyalaya Belgavi)

       OBJECTIVE OF THE STUDY:

Primary

• To evaluate the efficacy of Drakshadi Leha in Kaphaja Kasa in children

Secondary

• To compare the effect of Drakshadi Leha over Talisadi Churna in Kaphaja Kasa in children

RESEARCH QUESTION

• Is Drakshadi Leha effective in Kaphaja Kasa of 5 to 10 years children?

HYPOTHESIS:

H0

• There will be no effect of Drakshadi Leha over Talisadi churna at the age of 5 to 10 years in Kaphaja Kasa

H1

• There will be effect of Drakshadi Leha over Talisadi churna at the age of 5 to 10 years in Kaphaja Kasa

                                                     RESEARCH DRUG

• Drakshadi yoga

Drugs

Rasa

Veerya

Vipak

Guna

Karma

|Draksha

Madhura

sheeta

Madhura

Guru Snigdha

Kasahara

|Pippali

Katu

Anushna Sheeta

Madhura

Laghu Snigdha Tiksna

Kasahara

|Shunthi

Katu

Ushna

Madhura

Laghu Snigdha

Deepan

TABLE OF DRUG REVIEW (Drakshadi yoga)

SANSKRIT NAME

LATIN NAME

FAMILY

OFFICIAL PART

PRAPORTION

COLLECTION METHOD

|Draksha

Vitis

vinifera

Linn.

Vitaceae

Phala

1 part

GMP certified pharmacy

|Pippali

Piper

longum

Linn.

Piperaceae

Phala

1 part

GMP certified pharmacy

|Shunthi

Zinger

officinale

Rosc.

Zingiberaceae

Shushkakand

1 part

GMP certified pharmacy

PACKAGING AND STORAGE

Packaging from GMP Certified Ayurveda Pharmacy and storage from MRC

Drug Preparation Method

Drakshadi yoga will be prepared as per Standard Operative Procedures double quantity of the honey will be added for preparation of Drakshadi leha

Analysis: Drakshadi Leha & Talisadi churna will be analysed as per the API standard in K.L.E.U.’s Shri B.M.K. Ayurveda Mahavidyalaya pharmacy, Shahapur, Belagavi

STUDY TYPE

Interventional

STUDY DESIGN

Prospective

MASKING

Open label

CONTROL

Controlled

END POINT

Efficacy

Multiple Groups

Group Name

Description

|GROUP-A

15

|GROUP-B

15

Total Number of Subjects

30

DIAGNOSTIC CRITERIA

The diagnosis is mainly based on lakshanas of Kaphaja kasa as described in Ayurvedic classics

• Kasa
• Aruchi
• Chardi
• Peenasa
• Shira shoola

INCLUSION CRITERIA

• Patients of either sex aged between of 5 to 10 years
• Patients with classical Kaphaja Kasa lakshana(pinasa, aruchi, chardi)

EXCLUSION CRITERIA

• Patients below age group of 5 year and above 10 year
• Lobar pneumonia
• Known case of T.B, COPD
• All types of Kasa except Kaphaja kasa lakshan will be excluded
• Other systemic illness necessitating treatment other than for co

GROUPS & INTERVENTION INCLUDING FOLLOW UP:

NAME OF THE GROUP

SAMPLE SIZE

INTERVENTION WITH DOSE

DURATION

FOLLOW UP

|GROUP-A

15

Drakshadi leha ,

Doses in gms TDS 5yr-5gms/day ,                         6yr-6gms/day , 7yr-7gms/day ,

8yr-8gms/day ,9yr-9gms/day ,

10yr-10gms/day

5 days

1st- 5th day, 2nd-10th day

|GROUP-B

15

Talisadi churna,

Doses in gms TDS 5yr-5gms/day , 6yr-6gms/day , 7yr-7gms/day ,

8yr-8gms/day ,9yr-9gms/day ,

10yr-10gms/day

5 days

1st- 5th day, 2nd-10th day

SOP

All the raw drugs required for the preparation for Drakshadi yoga are to be made into churna separately and mix them homogeneously in equal quantity to prepare Drakshadi yoga and add double quantity of honey to prepare Drakshadi leha

ASSESSMENT CRITERIA

OBJECTIVE PARAMETERS

Added sounds

1. Wheeze[12]

• Marked poly2phonic wheezing all over the lung field           - Grade 04
• Polyphonic moderate wheezing all over the lung field           - Grade 03
• Marked polyphonic wheezing limited to zones                      - Grade 02
• Mild monophonic wheeze present                                          - Grade 01
• Wheezing absent                                                                     -  Grade 00

2. Crepitation[12]

• Scattered all over the lungs field                                            - Grade 03
• Distributed here and there in all the zones                             - Grade 02
• Present in one or two zones                                                    - Grade 01
• Absent crepitation                                                                   - Grade 00

3. Sputum[12]

• Thick large quantity of solid white/yellow /Green sputum     - Grade 03
• Moderately thick slightly white in color                                 - Grade 02
• Serous expectoration with traces of thick sputum                  - Grade 01
• No productive cough                                                              - Grade 00

  SUBJECTIVE PARAMETERS

Classical symptom of Kaphaja kasa like

1. Peenasa(nasal discharge)[10]

• Yellowish nasal discharge with  large quantity with headache          - Grade 03
• Yellowish nasal discharge with heaviness of head                             - Grade 02
• Nasal discharge in less quantity                                                          - Grade 01
• No nasal discharge                                                                              - Grade 00

2. Chardi(vomiting)[11]

• More than 4 episodes                                                                          - Grade 03
• 2-4 episodes                                                                                        - Grade 02
• 1-2 episodes                                                                                        - Grade 01
• Absent of vomiting                                                                             - Grade 00

3. Aruchi(loss of appetite)[11]

• Patient avoid food                                                                              - Grade 03
• Sometimes takes food properly, most of time avoid                          - Grade 02
• Less oral intake compare to routine diet                                             - Grade 01
• Take normal diet                                                                                 - Grade 00

4. Number of bouts of cough[12]

The number of bouts of cough in one hour were noted in each patient and graded as follow

• More than 8 bouts of cough                                                                - Grade 03
• 3 to 7  bouts of cough                                                                         - Grade 02
• Less than 3 bouts of cough                                                                 - Grade 01
• Absence of bout of cough                                                                  - Grade 00

5. Duration of bouts of cough[12]

The duration of each bout of cough in seconds is observed and the duration of 15 such bouts is counted and mean time of cough is calculated-

• Duration of cough more than 15 seconds                                           - Grade 04
• Duration of cough 10-15 seconds                                                       - Grade 03
• Duration of cough in between 5-9 seconds                                        - Grade 02
• Duration of cough less than 5 seconds                                               - Grade 01
• Absence of cough                                                                               - Grade 00

6. Disturbance of sleep[12]

• Cough always disturbs sleep                                                               - Grade 03
• Gets cough before sleeping or wakes children  in the  morning         - Grade 02
• Cough occasionally disturbs sleep                                                      - Grade 01
• Doesn’t interfere with sleep                                                                - Grade 00

FREQUENCY OF ASSESSMENT

2 times

STATISTICAL METHODS TO ANALYSE THE DATA

Man whitney U test

EXPECTED OUTCOMES

• Drakshadi leha would help in the management of Kaphaja Kasa in children more efficiently than Talisadi churna.

WITHDRAWAL CRITERIA

• During the course of the study if patient develops any untoward effect then the patient will be withdrawn from the study

RESCUE MEDICATION

In case of any condition suggestive of possible deterioration of health appropriate measure will be taken like facilitation in consulting the specialist of the concerned field